| CTRI Number |
CTRI/2019/04/018448 [Registered on: 08/04/2019] Trial Registered Prospectively |
| Last Modified On: |
04/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of standard exercise protocol versus physical activity counselling on blood sugar control and outcome of pregnancy in women diagnosed with gestational diabetes mellitus |
|
Scientific Title of Study
|
Effects of standard antenatal exercise protocol versus physical activity counselling on glycemic control and perinatal outcome in women diagnosed with gestational diabetes mellitus: Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandana Vidya Shankar |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of OBG
Kasturba Medical College, Manipal
Udupi Kasturba Medical College, Manipal
Udupi Udupi KARNATAKA 576 104 India |
| Phone |
8105601617 |
| Fax |
|
| Email |
chandanavidyashankar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Akhila Vasudeva |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of OBG
Kasturba Medical College, Manipal
Udupi Kasturba Medical College, Manipal
Udupi Udupi KARNATAKA 576 104 India |
| Phone |
9591614792 |
| Fax |
|
| Email |
akhilavasudeva@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrRoopa |
| Designation |
Associate Profesor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of OBG
KMC Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9008415729 |
| Fax |
|
| Email |
roopasarun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded - Primary Investigator
Dr.Chandana Vidya Shankar
Department of OBG
Kasturba Medical College, Manipal
Udupi
Karnataka |
|
|
Primary Sponsor
|
| Name |
DrChandana Vidya Shankar |
| Address |
Department of OBG
Kasturba Medical College
Manipal
Udupi
Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chandana Vidya Shankar |
Kasturba Hospital |
Antenatal clinic
Department of OBG
Kasturba Hospital,
Madhav Nagar, Manipal Udupi KARNATAKA |
8105601617
chandanavidyashankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O992||Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physical Activity Counselling |
Patients counselled by obstetrician to improve physical activity. These patients will be counselled during their regular antenatal checkup as per hospital protocols and intervention will continue till delivery |
| Intervention |
Standard Antenatal exercise protocol |
structured antenatal exercise program prescribed by physiotherapist.
Patient will continue exercise regimen as explained by the physiotherapist at home. These patients will be followed up during their regular antenatal check up at Kasturba Hospital. This intervention will continue till delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women diagnosed to have GDM between 24-28 weeks |
|
| ExclusionCriteria |
| Details |
1.Overt diabetes mellitus GDM diagnosed after 28 weeks
2.Any factor increasing the risk of preterm labor
3.Hemodynamically significant heart disease Restrictive lung disease
4.Incompetent cervix/cerclage
5.Multiple gestation at risk for premature labor
6.Persistent second or third trimester bleeding
7.Placenta praevia after 26 weeks gestation
• Ruptured membranes
• Pregnancy induced hypertension
• Non compliant to exercise protocol
• Non compliant to diet
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic Control |
24-28 weeks
28 - 32 weeks
32-36 weeks
36 weeks to 40 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WHO-GPAQ |
8 weeks after intervention |
| WHO-BREF |
8 weeks after intervention |
| Perinatal outcome |
following delivery |
| antenatal complications of GDM |
24 weeks till delivery |
| Route of delivery |
delivery |
| Intrapartum complications |
during labour |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/04/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
RCT will be conducted at Antenatal Clinic, Kasturba Hospital, Manipal. Ethical clearance by Institutional Ethical Committee (IEC), Kasturba Hospital Manipal will be taken. Pregnant women who have been previously screened by the Obstetrician and confirmed with gestational diabetes mellitus (FBS 92mg/dl, 1hr 181mg/dl, 2hr 153mg/dl in 75gm of OGTT –According to IADPSG criteria) between 24-28 weeks of gestation will be enrolled for the study. They will be screened for inclusion and exclusion criteria through proforma where baseline demographic characteristics will be obtained. A written informed consent from the participants will be taken after a brief explanation about the procedure.
There are two accepted methods of increasing physical activity as a therapeutic measure to improve glycemic control among GDM mothers as practiced in our institution. One is a standard and structured antenatal exercise program prescribed by physiotherapist. Second is a counseling provided by the obstetrician on improving physical activity at home. Participants are divided into two groups, based on block randomization. In first group, participants receiving standard antenatal exercise protocol will be given a booklet describing the components of this structured exercise program. They will be given a detailed explanation on these exercises by a physiotherapist, along with some demonstration. Participants will be performing these exercises at home. Weights used will be personalized to patients condition. They would maintain a log book which would be scrutinized by the physiotherapist during their subsequent regular check ups. They would be motivated to ensure compliance, during these check ups. In the second group, treating obstetrician would give them a counseling on improvement on their routine physical activity at home and work place, along with some walking.
All participants will be prescribed Medical Nutrition Therapy (MNT) according to maternal BMI and sugar levels, as per hospital protocol. Participants are given medications to achieve glycemic target if necessary, as deemed necessary by the treating obstetrician.
Periodic blood sugar levels are monitored as part of standard hospital protocol. Perinatal outcome including mode of delivery, ultrasound biometry, AFI, birth weight, neonatal outcome, and perinatal complications are noted down.
Physical activity of all participants will be assessed based on WHO-GPAQ questionnaire, and quality of life will be assessed based on WHO-QOL BREF questionnaire before starting intervention and after 8 weeks of intervention. Physiotherapeutical intervention will continue till delivery. Compliance to diet and exercise will be assessed during their regular visits.
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